Registration of the meeting of representatives of Roche Slovensko s.r.o. with representatives of MZ SR on 16.01.2016 at 1 p.m. at MZ SR

For the Ministry of Health of the Slovak Republic (hereinafter "the Ministry'):

•  director of the Division of Classification and Pricing, Mgr. Miriam Vulevová, MBA

•  director of Health Technology Assessment Department, MVDr. Mgr. Peter Mask, MPH

•  official of the Department of Classification and Pricing, Jana Ivanova

For Roche Slovensko s.r.o. (hereinafter referred to as "Roche"):

•  Mr Simona Igaz, Market Access and Corporate Affairs Director

•  Radovan Slutka, Medical Adviser

The meeting took place at the request of Roche.

The meeting was opened by the Director of the Department of Classification and Pricing, Mgr. Miriam Vuleva, MBA.

Roche:

The pharmaceutical company submitted an application for the conditional inclusion of the medicinal product Perjeta 420 mg concentrate for solution for infusion with SUKL code 4491A to list categorised medicinal products (hereinafter referred to as "the application'). Roche presented the options participation in the reimbursement of the cost of on-the-spot medicines in accordance with the applicable indication restrictions after the end of paid treatment by the health insurance undertaking. To Perjeta is proposed for an indication restriction based on Public health insurance for the treatment of metastatic breast cancer to pay a maximum of 27 treatment cycles according to Roche information has also confirmed the pharmaco-economic analysis of the medicinal product.

MZ SR:

The Ministry considers that the current legislation does not address the model co-financing of reimbursement of continued treatment in non-approved patients indication restriction. An amendment to Law No 363/2011 is currently under preparation the scope and conditions of reimbursement of medicinal products, medical devices and dietetic foods based on public health insurance and on change; and the addition of certain laws, as amended (hereinafter referred to as the It will address, among other things, new patterns of the way reimbursement of the price of the medicine and possible participation of pharmaceutical companies. At the request received will be made in accordance with the applicable legislation.